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CTRI Number  CTRI/2017/12/010946 [Registered on: 21/12/2017] Trial Registered Retrospectively
Last Modified On: 18/12/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two laser platforms of myopia vision correction 
Scientific Title of Study   Comparison of Next Generation Laser Techniques of Myopia Correction: iDesign vs. SMILE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Shetty 
Designation  Vice Chairman 
Affiliation  Narayana Nethralaya 
Address  Division of Cornea and Refractive services, 2nd floor, 121C Chord Road, Rajajinagar, Bangalore, Karnataka

Bangalore
KARNATAKA
560010
India 
Phone  9611102568  
Fax    
Email  drrohitshetty@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Rohit Shetty 
Designation  Vice Chairman 
Affiliation  Narayana Nethralaya 
Address  Division of cornea and refractive servuces, 2nd floor, 121C Chord Road, Rajajinagar, Bangalore, Karnataka

Bangalore
KARNATAKA
560010
India 
Phone  9611102568  
Fax    
Email  drrohitshetty@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Rohit Shetty 
Designation  Vice Chairman 
Affiliation  Narayana Nethralaya 
Address  Division of cornea and refractive services, 2nd floor, 121C Chord Road, Rajajinagar, Bangalore, Karnataka

Bangalore
KARNATAKA
560010
India 
Phone  9611102568  
Fax    
Email  drrohitshetty@yahoo.com  
 
Source of Monetary or Material Support  
Narayana Nethralaya 121C Chord Road, Rajajinagar, Bangalore-560010, Karnataka 
 
Primary Sponsor  
Name  Narayana Nethralaya 
Address  121C Chord Road, Rajajinagar, Bangalore 560010, Karnataka 
Type of Sponsor  Other [Hospital and Nonprofit research institute] 
 
Details of Secondary Sponsor  
Name  Address 
Abbott Medical Optics  150 Beach Road 27 01 Gateway West Singapore 189720 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Abhijit Sinha Roy  Narayana Nethralaya  Imaging and Biomechanics Division, 3rd floor, 258A Hosur Road, Health City Bommasandra, Bangalore 560099
Bangalore
KARNATAKA 		 9740566833

asroy27@yahoo.com 
Rohit Shetty  Narayana Nethralaya  Division of cornea and refractive services, 2nd floor, 121C Chord Road Rajajinagar Bangalore 560010 Karnataka
Bangalore
KARNATAKA 		 9611102568
8023377329
drrohitshetty@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Nethralaya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients opting for refractive surgery for correction of myopia and astigmatism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Small incision lenticule extraction   The other group will undergo Small incision lenticule extraction for treatment refractive error (Carl Zeiss, Germany). 
Intervention  Wavefront guided laser assisted in situ keratomileusis  One group will undergo Wavefront guided laser assisted in situ keratomileusis using iDesign platform (Johnson and Johnson, USA).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients should be between 18 to 50 years of age.
Patient must have stable myopia for a minimum period of one year (a change of 0.25D or less) as documented by prior clinical records or current spectacle correction.
Patient must have a corrected distance visual acuity (CDVA) of 0.8 or better
Patient must have a spherical equivalent refraction less than −10D
Patient must have refractive astigmatism less than 3D 
 
ExclusionCriteria 
Details  Patient must not have a central corneal thickness less than 480 micrometer
Patient must not have a calculated residual stromal bed thickness of less than 250 micrometer after the surgery
Patient must not have symptoms or signs of keratoconus, diabetes, collagen vascular disease, pregnancy, breastfeeding and any prior ocular surgery.
Patient must not have an interocular difference of more than 1.00 diopter of
spherical or 0.50 D of cylindrical refractive error.
Patient must not be on chronic systemic steroids or other medication that can affect wound healing.
Patient must not be allergic to primary or alternative medications.
Patient must not be using rigid contact lenses for the last three weeks or soft contact lenses for at least 1 week before the preoperative evaluation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Uncorrected and distance visual acuity, Wavefront aberrometry  Pre-surgery, 1 month, 3 month, 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
Corneal tomography, Biomechanics of the cornea, ocular surface discomfort (OSDI score)  Pre-surgery, 1 month, 3 month, 6 month 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/01/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
iDesign is a promising new technique to treat myopia with astigmatism using ocular
aberrations measured with a high resolution wavefront sensor.[1,2] Early studies with
iDesign platform has established its safety and efficacy in correction of myopia with
fewer patients reporting night vision problems.[1,2] In keratoconus, iDesign has also
provided excellent outcomes following collagen crosslinking.[3] SMILE is a recent
technique that eliminates creation of flap and appears to achieve similar refractive
outcomes as conventional LASIK but with less dryness, less inflammation and
faster wound healing.[4,5] SMILE corrects lower order aberrations only.[4,5] Thus,
a comparative assessment of iDesign and SMILE is necessary since iDesign can
potentially give better visual outcomes with lower volume of tissue removal. If lower
volume of tissue is removed, it is also hypothesized that the corneal would be more
stable biomechanically.[5] Further, SMILE does not provide any correction of higher order
aberrations. With the inclusion of higher order aberrations in the iDesign treatment plan,
it is hypothesized that both short and long term outcomes will be better with iDesign
than with SMILE.

References
1. Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Outcomes of wavefrontguided laser in situ keratomileusis using a new-generation Hartmann-Shack
aberrometer in patients with high myopia. J Cataract Refract Surg. 2015; 41(9):
1810-9.
2. Schallhorn SC, Venter JA, Hannan SJ, Hettinger KA. Wavefront-Guided
Photorefractive Keratectomy with the Use of a New Hartmann-Shack
Aberrometer in Patients with Myopia and Compound Myopic Astigmatism. J
Ophthalmol. 2015; 2015: 514837.
3. Shaheen MS, Shalaby Bardan A, Piñero DP, Ezzeldin H, El-Kateb M, Helaly
H, Khalifa MA. Wave Front-Guided Photorefractive Keratectomy Using a HighResolution Aberrometer After Corneal Collagen Cross-Linking in Keratoconus.
Cornea. 2016; 35(7): 946-53.
4. Denoyer A, Landman E, Trinh L, Faure JF, Auclin F, Baudouin C. Dry eye
disease after refractive surgery: comparative outcomes of small incision lenticule
extraction versus LASIK. Ophthalmology. 2015; 122(4): 669-76.
5. Reinstein DZ, Archer TJ, Gobbe M. Small incision lenticule extraction (SMILE)
history, fundamentals of a new refractive surgery technique and clinical
outcomes. Eye Vis (Lond). 2014;1:3.

 
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